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FDA 510(k)

LIASYS 600 電解質測量系統，LIASYS 600 肌酐試劑，LIASYS 600

K 號：K172232 · 2019-06-12

申請人Ams Diagnostics
決定日期2019-06-12
產品代碼JGS
諮詢委員會CH
決定相當於

器材摘要

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 is the device name listed in this FDA 510(k) record. The listed applicant is Ams Diagnostics. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K172232. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600?

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is Ams Diagnostics. The 510(k) number is K172232.

When did LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 receive FDA 510(k) clearance?

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 received FDA 510(k) clearance on 2019-06-12, under 510(k) number K172232.

Who is the listed applicant for LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600?

The FDA 510(k) record lists Ams Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600?

The FDA product code for LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 is JGS.

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